Alexandre Oliveira Ferreira 1 , Joana Torres 1 , Elidio Barjas 1 , Joana Nunes 1 , Luisa Glória 1 , Rosa Ferreira 1 , Manuel Rocha 1 , Sónia Pereira 1 , Sofia Dias 1 , Antonio Alberto Santos 1 , Marília Cravo 1 Show Affiliations »
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BACKGROUND AND STUDY AIMS: Propofol provides the best sedation in colonoscopy. The safety of non-anesthesiologist administration of propofol (NAAP ) is still a matter of debate. The aim of the current study was to evaluate sedation safety, colonoscopy quality, and patient satisfaction with NAAP . PATIENTS AND METHODS: The study was a single-blinded, noninferiority, randomized controlled trial comparing NAAP (Group A) with anesthesiologist-administered sedation (Group B) performed at a single academic institution. Patients (18 - 80 years) who underwent colonoscopy and were at low anesthetic risk (American Society of Anesthesiologists class I - II) were included . The primary end point was the incidence of adverse events . Secondary end points were propofol dose, patient satisfaction and pain, colonoscopy quality indicators, and procedure and recovery times . RESULTS: A total of 277 patients were included in the analysis . The incidence of adverse events was 39.3 % in Group A and 39.0 % in Group B (absolute difference - 0.3 %, 95 % confidence interval [CI] - 12.0 % to 11.4 %; P = 0.959). There were no sentinel adverse events . The following interventions (Group A vs. Group B) were necessary: atropine administration (0 % vs. 5.5 %; P = 0.004); airway repositioning (8.7 % vs. 4.7 %; P = 0.196); increased oxygen administration (6.7 % vs. 3.9 %; P = 0.317), and increased fluid rate (2.7 % vs. 0.8 %; P = 0.379). There were no differences in cecal intubation and adenoma detection rates . Recovery times were longer in Group B (58 ± 33 vs. 67 ± 29 minutes; P = 0.032). There were no differences in mean propofol dose, withdrawal time, painless colonoscopy, satisfaction, and amnesia . All but two patients (Group B) were willing to repeat the colonoscopy. CONCLUSIONS: NAAP is equivalent to anesthesiologist-administered sedation in the rate of adverse events in a low risk population. TRIAL REGISTRATION: ClinicalTrials.gov (NCT02067065). © Georg Thieme Verlag KG Stuttgart · New York.
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BACKGROUND AND STUDY AIMS: Propofol provides the best sedation in colonoscopy. The safety of non-anesthesiologist administration of propofol (NAAP ) is still a matter of debate. The aim of the current study was to evaluate sedation safety, colonoscopy quality, and patient satisfaction with NAAP . PATIENTS AND METHODS: The study was a single-blinded, noninferiority, randomized controlled trial comparing NAAP (Group A) with anesthesiologist-administered sedation (Group B) performed at a single academic institution. Patients (18 - 80 years) who underwent colonoscopy and were at low anesthetic risk (American Society of Anesthesiologists class I - II) were included. The primary end point was the incidence of adverse events. Secondary end points were propofol dose, patient satisfaction and pain , colonoscopy quality indicators, and procedure and recovery times. RESULTS: A total of 277 patients were included in the analysis. The incidence of adverse events was 39.3 % in Group A and 39.0 % in Group B (absolute difference - 0.3 %, 95 % confidence interval [CI] - 12.0 % to 11.4 %; P = 0.959). There were no sentinel adverse events. The following interventions (Group A vs. Group B) were necessary: atropine administration (0 % vs. 5.5 %; P = 0.004); airway repositioning (8.7 % vs. 4.7 %; P = 0.196); increased oxygen administration (6.7 % vs. 3.9 %; P = 0.317), and increased fluid rate (2.7 % vs. 0.8 %; P = 0.379). There were no differences in cecal intubation and adenoma detection rates. Recovery times were longer in Group B (58 ± 33 vs. 67 ± 29 minutes; P = 0.032). There were no differences in mean propofol dose, withdrawal time, painless colonoscopy, satisfaction, and amnesia . All but two patients (Group B) were willing to repeat the colonoscopy. CONCLUSIONS: NAAP is equivalent to anesthesiologist-administered sedation in the rate of adverse events in a low risk population. TRIAL REGISTRATION: ClinicalTrials.gov (NCT02067065). © Georg Thieme Verlag KG Stuttgart · New York.
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Year: 2016
PMID： 27100716 DOI： 10.1055/s-0042-105560
Source DB: PubMed Journal: Endoscopy ISSN： 0013-726X Impact factor: 10.093